Insulin Requirement for Pure-protein Meal in Children With Type 1 Diabetes on Insulin Pumps.

Medical University of Warsaw

Status and phase: Unknown; Phase 4

Conditions: Diabetes type1

Treatments: Drug: Insulin aspart; Drug: Insulin glulisine; Drug: Insulin lispro

Study type: Interventional

Funder types: Other

Identifiers

NCT02685449

Białko_5h

Details and patient eligibility

About

This is a randomized, cross-over study. The aim of this study is to compare the post-prandial glycaemic variability after pure protein meal following with an administration of square-wave bolus of meal-insulin or without any meal-insulin bolus on the other day.

Prolonged post-prandial glycaemic variability will be identified using the self-monitoring of blood glucose (10-point curve) and CGMS.

Full description

The square-wave bolus (for meals rich in fat and/or protein) is evenly delivered over several hours as programmed by the patient. The required insulin dose will be calculated based on patient's insulin-exchange ratio. Pure protein meal will be given 3 hours after a first breakfast.

To provide the minimal impact of the previous breakfast, all patients will receive up to 120 kcal of carbohydrates and <100 kcal from protein and fat for the first breakfast (without any extended bolus) Patients receive a standardized pure protein meal at a second breakfast time. Meal insulin will be given as a square bolus or no meal -insulin will be given at all. The 5h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG) (every 30 minutes) and continuous glucose monitoring system (CGMS). The intervention is taking part under in-patient clinical conditions.

Enrollment: 70 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• duration of type 1 diabetes longer than 12 months
• insulin pump therapy longer than 3 months
• written informed consent by patients and parents
• insulin requirement more than 0,5 units/kg/day

Exclusion criteria

• diabetes related complications (e.g. nephropathy)
• chronic kidney diseases
• any disease judged by the investigator to affect the trial
• withdrawal of consent to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

group A

Placebo Comparator group

Description:

On the first study day, insulin bolus was not given before a standardized pure protein meal. On the second day, pre-breakfast insulin was given as a square-wave bolus before the same standardized pure protein meal. The fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial. Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine

Treatment:

Drug: Insulin lispro

Drug: Insulin glulisine

Drug: Insulin aspart

group B

Active Comparator group

Description:

On the first study day, pre-breakfast insulin was given as a square-wave bolus before a standardized pure protein meal. On the second day, insulin bolus was not given before the same standardized pure protein meal. The fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial. Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine

Treatment:

Drug: Insulin lispro

Drug: Insulin glulisine

Drug: Insulin aspart